As the first session of the 118th Congress continues, FDAnews will track important pending legislation that has been acted on since July 1, to keep you updated on laws and…

The election of newly installed Speaker of the House Mike Johnson (R-La.) means the impending government shutdown on Nov. 17 almost certainly won’t occur, says Steven Grossman, executive director of…

An upstream occlusion alarm in certain of B. Braun’s infusion pumps that may sound when no occlusion exists and cause the pump to stop pumping caused the company to issue…

In a win for Masimo, the U.S. International Trade Commission (ITC) banned the importation of Apple watches with light-based oximetry technology that monitors heart rate and blood oxygen because the…

Over the past week, the FDA issued draft guidance on communications of off label uses of approved/cleared medical products and remote inspections of drug manufacturing and BIMO facilities. Source: Drug…

A new publicly searchable database contains detailed information on all 141 Alzheimer’s disease (AD)-targeting drugs involved in 187 active clinical trials in the U.S. and around the world. Source: Drug…

Sen. Bernie Sanders (I-Vt.) sent a letter to the HHS Inspector General seeking investigation into an NIH proposal granting an exclusive patent license to an “obscure company linked to a…

The FDA has issued a warning letter to Illinois drugmaker Abbott Laboratories regarding its Similac Probiotic Tri-Blend for infants, over marketing claims that render the product an unapproved new drug…

Oncologists were more likely to provide low-value cancer care drugs after receiving money from the pharmaceutical companies that make those drugs, raising questions about the harm caused to patients by…

The FDA’s guidance on developing topical corticosteroids provides ANDA applicants with recommendations on pilot and pivotal studies to assess bioequivalence of the drugs. Source: Drug Industry Daily